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Complete title: A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
|Research Study Number||20121671|
|Principal Investigator||Scott Tykodi, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Men & women =/> 18 years of age
- Histologic confirmation of Renal cell carcinoma (RCC) with clear-cell component
- Advanced/metastatic RCC
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
- No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
- Karnofsky Performance Score =/> 70%
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
- Any active known or suspected autoimmune disease.
- Uncontrolled adrenal insufficiency
- Active chronic liver disease
- Prior malignancy active within past 3 years, except for locally curable cancers
Other exclusion criteria may apply.
Kidney Cancer; Renal Cancer; Solid Tumors
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